Diabetes is the seventh leading cause of death in the United States, and accounts for around $245 billion in medical costs and lost productivity each year, according to data from The State of Obesity, which drew information from CDC's Behavioral...
A hiring freeze put into place by Pres. Trump could damage efforts to make the case that the dietary supplement industry is effectively regulated, experts say.
Pres. Trump’s executive order requiring new regulations to be offset by the elimination of existing ones could wreak havoc with the pending roll-out of long awaited rules, such as the NDI draft guidance, observers say.
Days after President Trump signed an executive order that freezes some regulations and draft guidance documents, FDA offers to help food industry associations draft their own guidance documents to help “capture the best practices” and boost industry compliance...
As the deadlines for regulations painstakingly developed under the Food Safety Modernization Act begin to go into effect, compliance by producers, suppliers and manufacturers alone will not be enough to stop food borne illness outbreaks, a top FDA official...
Amid reports that new products containing the banned stimulant ingredient DMAA continue to find their way onto the market one company has persisted in marketing them openly.
The Trump Administration’s regulatory freeze announced last week could significantly impact how the Nutrition Facts Label final rule and regulations related to the Food Safety Modernization Act are interpreted and enforced even though they passed well...
The rapid reconstitution of the Dietary Supplements Caucus shows that despite the unprecedented tumult in national politics, the support for the industry remains as strong as ever within the halls of Congress.
For one expert the question of so called synthetic botanicals goes deeper than whether they are legal. It’s a question that drives to the core of what the dietary supplement industry ought to represent.
The importance of having a detailed quality agreement with your contract manufacturer has been driven home by a recent warning letter issued to a marketer of sports nutrition products.
The updated New Dietary Ingredients draft guidance is an attempt to over regulate and weaken the dietary supplement industry with no increase in public safety, according to comments filed recently by finished goods manufacturer Jarrow Formulas.
By Loren Israelsen, president, United Natural Products Alliance
2016 felt like the year of hammer blows and the squeeze play, with the finale the unpredicted win of Donald Trump as President. I count myself among those who close this year pondering the state of affairs globally, nationally, and personally.
At this time of year, many of us take advantage of the changing calendar and assess where we are as an industry. Typically, this exercise is a broad-based reflection evaluating a variety of topics. This year a group of leading industry experts were asked...
By Michael McGuffin, president, American Herbal Products Association
Several events in 2016 will impact the industry in 2017 and future years. The 2016 election results tops that list. Like most other industries in the U.S., the herbal products industry will be closely watching the incoming Trump administration and Republican-controlled...
Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.
The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.
The current NDI draft guidance is unlikely to improve compliance or the quality of submissions and should be rewritten. That’s the opinion expressed by the American Herbal Products Association in comments it filed with FDA.
News that the US Food and Drug Administration (FDA) has approved a qualified health claim about high amylose maize resistant starch as a weapon in the fight against type 2 diabetes will start a much-needed conversation about the fiber, say experts.
The Natural Products Association has urged FDA to cease its attempt to apply food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.
The Council for Responsible Nutrition has urged the Food and Drug Administration to broaden the definition of dietary ingredients in its NDI draft guidance and to step back from requiring filings on new finished products.
Comments on FDA’s NDI guidance have flooded in, and several themes have emerged. Commenters observed that the guidance will stifle competition, is overburdensome and will contribute little to the overall safety of dietary supplements.
Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those companies willing to go through accepted channels,...
A recent presentation to FDA that was well received made the case that simple changes in fermentation media would not result in the creation of a New Dietary Ingredient.
Retailing giant GNC has entered into an wide-ranging agreement with the Department of Justice aimed at preventing potentially unlawful ingredients and supplements from showing up on its shelves.
Motivated by transparency, the US Food and Drug Administration has released tens of thousands of adverse event reports for dietary supplements, but does the data actually allow for any conclusions to be drawn?
In a recently issued draft guidance, the Food and Drug Administration has shed more light on the process of determining what’s a fiber and what might not be—information that could be of critical importance for the marketers of prebiotics.
The American Botanical Council and the American Herbal Products Association have urged the DEA to back off its plan to ban kratom. The groups took slightly different tacks in their comments, with ABC focusing on how the move could restrain research while...
Kratom should not be a controlled substance because it poses little risk for abuse and dependance, according to a drug expert whose analysis was commissioned by an advocacy group.
Adding kratom to the US food supply could lead to serious unintended consequences as the US struggles with opioid addiction, says the Natural Products Association in comments submitted to the US DEA.
A “clear and reasonable warning” must be used from December 4, 2016 on products being sold in California containing “Aloe vera, non-decolorized whole leaf extract” and “goldenseal root powder” compliant with Prop 65, unless otherwise exempted.
The vast majority of the world’s supply of omega-3 fatty acids comes from the Peruvian anchovy fishery. As the fishery recovers from depressed stocks caused by an El Niño event, the sustainability picture remains clouded, as one major certification body...
Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...
The International Probiotics Association has submitted a citizen petition to the FDA to require the labeling of probiotic ingredients in dietary supplements as colony forming units (CFUs) instead of by weight.
Regulatory definitions remain hazy for probiotics and prebiotics, but efforts are underway to further nail down where these ingredients fit within the overall structure that governs dietary supplements.
The European Food Safety Authority (EFSA) has said l-ergothioneine is safe for use in food and supplements in a novel food evaluation that settles EU member state fears it may increase the risk of diabetes mellitus and inflammatory diseases like Crohn's...
Hemp and marijuana come from the same plant species, but in terms of psychoactive constituents, the two are very different. Will the recent legalization of recreational marijuana in some states positively benefit the hemp industry as well?
Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.
Donald Trump’s stunning upset victory has dumbfounded pundits both at home and abroad. But it is of less importance for the dietary supplement industry than the result of the down ticket races, trade group executives said this morning.
Donald Trump’s historic victory leaves dietary supplement industry observers wrestling with the question of what will be the character of his administration, when the candidate himself has taken so many positions, some of which match standard conservative...
FDA has not moved vigorously to police delivery formats that fall into gray areas, but that doesn’t mean that dietary supplement companies using these modes can assume they’re flying completely under the radar.
Trade organizations representing the dietary supplement industry urged the Food and Drug Administration to reverse its tentative conclusion that vinpocetine, despite several successful NDI filings, is no longer a legal dietary ingredient.
Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.
Fishing will be banned in a newly protected area of the Southern Ocean in Antarctica the size of the UK and France combined following an agreement at a Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) meeting.
If the FDA’s decision to wade into the ‘natural’ debate seemed like an act of sadomasochism, its decision to re-examine the criteria underpinning ‘healthy’ claims on food labels looks set to be equally painful, judging by the first wave of public comments...
The Council for Responsible Nutrition has submitted comments to a Health Canada that urges the agency not to scrap the existing product registration system but rather to further refine it if that is deemed necessary and to better educate the public about...
